Bioprocess Division
1-1-2 Yurakucho, Chiyoda-ku, Tokyo 100-0006 Japan
Phone: +81 (0)3-6699-3782 Fax: +81 (0)3-6699-3784

Cover Sheet for BioOptimal MF-SL Safety Data SheetThis Safety Data Sheet for the United States (OSHA HCS1) and the European Union (EU CLP2) covers
BioOptimal MF-SL.

Hazard identification
OSHA HCS1 and EU CLP2 Classifications

ClassCategory
Pictogram
20% Ethanol used as preservation agent of BioOptimal MF-SL

Signal word

Information
for EU CLP2
H codeFlammable liquids

3

H226

Serious eye damage/irritation

2

H319

Carcinogenicity

1H350

Reproductive toxicity

1

Specific target organ toxicity single
exposure

3 (Respiratorytract irritation)

H335

Specific target organ toxicity single
exposure

3 (Narcoticeffects)

H336

Specific target organ toxicity
repeated or prolonged exposure

1

H372

Danger

H360

Hazard statements
H code
H226
H319
H335
H336
H350
H360
H372

Hazard statement
Flammable liquid and vapor
Causes serious eye irritation
May cause respiratory irritation
May cause drowsiness or dizziness
May cause cancer
May damage fertility or the unborn childCauses damage to liver through prolonged or repeated exposure

Precautionary statements for BioOptimal MF-SL for EU CLP2

P201: Obtain special instructions before use.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skinwith water/shower.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contactlenses, if present and easy to do. Continue rinsing.
P314: Get medical advice/attention if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice/attention.
OSHA HCS: 29 CFR Part 1910, Federal Register, Vol. 77, No. 58, March 26, 2012
EU CLP: Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008

12

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Safety Data Sheet
Section 1: Identification of the substance/mixture and of the company/undertaking
1.1. Product Identifier
Product/chemical name:

BioOptimal MF-SL

1.2. Relevant uses of product: Hollow fiber membrane for manufacturing of medical products
1.3.Contact information of Manufacturer/Supplier:Name of manufacturer:
Asahi Kasei Medical Co., Ltd.
Bioprocess Division
1-1-2 Yurakucho, Chiyoda-ku, Tokyo 100-0006 JAPAN
Tel: +81-3-6699-3782; Fax: +81-3-6699-3784
Email address: info.jp@ak-bio.com
Name of supplier (importer) in the EU:
N.V. Asahi Kasei Bioprocess Europe S.A.
Rue Colonel Bourg, 122, 1140 Brussels, Belgium
Tel: +32-2-526-0500; Fax: +32-2-526-0510
Email address: info.eu@ak-bio.com
Name of supplier (importer) in the US:
Asahi Kasei Bioprocess America, Inc.
1855 Elmdale Avenue, Glenview, IL 60026 USA
Tel: +1-847-556-9700; Fax: +1-847-556-9701
Email address: info.us@ak-bio.com
1.4. Emergency telephone number
In case of emergency, call the local poison control center.
Section 2: Hazard identification
Hazard identification is described based on 20 % ethanol used as preservation agent of thisproduct.
2.1. Classification of the substance or mixture
Classification according to OSHA HCS:
Physical Hazards
Flammable liquids: Category 3
Health Hazards
Serious eye damage/eye irritation: Category 2
Carcinogenicity: Category 1Reproductive toxicity: Category 1
Specific target organ toxicity single exposure: Category 3 (Respiratory tract irritation,Narcotic effects)
Specific target organ toxicity repeated or prolonged exposure: Category 1
Environmental Hazards

Not classified

Other Hazards

No information

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Safety Data Sheet for BioOptimal MF-SLClassification according to EU CLP:
Flam. Liq. 3: H226
Eye Irrit. 2: H319
Carc.
1A: H350
Repr.
1A: H360
STOT SE 3: H335
STOT SE 3: H336
STOT RE 1: H372
2.2. Label elements:
In accordance with OSHA HCS and EU CLP:
Pictogram(s)Signal word:

DangerHazard statements:
Flammable liquid and vapor (H226)
Causes serious eye irritation (H319)
May cause respiratory irritation (H335)
May cause drowsiness or dizziness (H336)
May cause cancer (H350)
May damage fertility or the unborn child (H360)
Causes damage to liver through prolonged or repeated exposure (H372)
Precautionary statements:
Prevention
Obtain special instructions before use. (P201)
Do not handle until all safety precautions have been read and understood. (P202)
Keep away from heat/sparks/open flames/hot surfaces. - No smoking. (P210)
Keep container tightly closed. (P233)
Ground/bond container and receiving equipment. (P240)
Use explosion-proof electrical/ventilating/ lighting/equipment. (P241)
Use only non-sparking tools. (P242)
Take precautionary measures against static discharge. (P243)
Do not breathe dust/fume/gas/mist/ vapors/spray. (P260)
Wash hands thoroughly after handling. (P264)
Do not eat, drink or smoke when using this product. (P270)
Use only outdoors or in a well-ventilated area. (P271)
Wear protective gloves/protective clothing/eye protection/face protection. (P280)
Response
IF ON SKIN (OR HAIR): Take off immediately all contaminated clothing. Rinse skin withwater/shower. (P302+P361+P353)
IF INHALED: Remove person to fresh air and keep comfortable for breathing. (P304+P340)
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if
present and easy to do. Continue rinsing. Get medical advice/attention if you feel unwell.
(P305+P351+P338+P314)
IF EYE IRRITATION PERSISTS: Get medical advice/attention. (P337+P313)

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IN CASE OF FIRE: Use water mist, dry chemical powder, fire foam or carbon dioxide toextinguish. (P370+P380)
Storage
Store in a well-ventilated place. (P403) Keep container tightly closed. (P233)
Store locked up. (P405)
Disposal
Dispose of contents/container in accordance with local/regional/national/international
regulations. (P501)
2.3. Other hazards:
In accordance with OSHA HCS: No information
In accordance with EU CLP: The substance does not meet the criteria for PBT or vPvB
according to Regulation (EC) No 1907/2006, Annex XIII.
Section 3: Composition/information on ingredients3.1. Mixtures
Product/chemical name: BioOptimal MF-SL
Materials:
Hollow Fiber Membrane: Polysulfone
Housing: Polysulfone
Sealant: Epoxy resin
Preservation agent: 20 % ethanol
Information on ingredients:
Chemical name
Ethanol
Water

Content (wt %)2080

CAS No.
64-17-57732-18-5

EC No.
200-578-6
231-791-2

Classification of ingredients contributing to EU CLP hazards classifications*:
Flam. Liq., 3, H226; Eye Irrit., 2, H319; Carc., 1A, H350; Repr., 1A, H360; STOT SE, 3, H335;
STOT SE 3, H336; STOT RE, 1, H372
*Full text of hazard statements is given in Section 16 of this Safety Data Sheet.

Section 4: First-aid measures
4.1. Description of first aid measures
IF INHALED: If you feel unwell, get medical advice/ attention immediately and at rest.
If symptoms continue, call a doctor/physician.
IF ON SKIN: Rinse with plenty of water.
If symptoms continue, call a doctor/physician.
IF IN EYES: Immediately rinse cautiously with water for 15 - 20 minutes. Remove contactlenses, if present and easy to do. Continue rinsing. If symptoms continue, call adoctor/physician.
IF SWALLOWED: Rinse mouth. Immediately get medical advice/attention.
4.2. Most important symptoms and effects, both acute and delayed
Causes eye irritation
May cause respiratory irritation
May cause drowsiness or dizziness
May cause cancer
May damage fertility or the unborn childCauses damage to liver through prolonged or repeated exposure

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May causes damage to central nervous system through prolonged or repeatedexposure
4.3. Indication of any immediate medical attention and special treatment needed
No information
Section 5: Fire-fighting measures
5.1. Extinguishing media
Suitable extinguishing media: Water mist, dry chemical powder, fire foam or carbon dioxide
Unsuitable extinguishing media: Applying direct water may be dangerous because fire
may expand to surroundings
5.2. Specific hazards arising from the substance or mixture
In case of fire, toxic decomposition products may be generated.
5.3. Advice for firefighters
Cut off any ignition sources and extinguish with an appropriate agent.
Cool the surrounding tank and the buildings with direct water jet to avoid risk of fire spreading.
Take action from windward.
Keep out except responsible personnel.
Move container to a safe area if it can be done without risk.
Section 6: Accidental release measures
6.1. Personal precautions, protective equipment, and emergency procedures
For non-emergency personnel:
Wear suitable protective equipment (see Section 8) e.g., safety gloves, protective mask
and/or protective glasses to prevent exposure.
For emergency responders:
Keep out except responsible personnel.
Wear suitable protective equipment described in “Section 8: Exposure controls/ personalprotection”
6.2. Environmental precautions
Avoid release into the environment because product may cause local effects.
6.3. Methods and materials for containment and cleaning up
Stop leak if you can do it without risk.
In case of small amounts, wipe off spilled material with waste or wiping cloth and collect itin an adequate waste container.
If case of large amounts, prevent leakage and enclose by embankment.
Do not eat or drink near handling and storage locations.
ELIMINATE all ignition sources (no smoking, flares, sparks or flames in immediate area).
Prevent to flowing into drains, sewers, basements or closed areas.
6.4. Reference to other sections
Refer to “SECTION 8: Exposure controls/personal protection” and “SECTION 13: Disposal
considerations” as appropriate.
Section 7: Handling and storage
7.1. Precautions for safe handlingProtective measures:Install appropriate equipment and wear suitable protective apparatus described in“Section 8: Exposure controls/ personal protection”.

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Keep away from heat/sparks/open flames/hot surfaces. No smoking.
Advice on general occupational hygiene:
Wash hands thoroughly after handling.
Do not eat, drink or smoke when using this product.
Wash contaminated clothing before reuse.
7.2. Conditions for safe storage, including any incompatibilities
Technical measures:Install appropriate equipment and wear suitable protective apparatus described in“Section 8: Exposure controls/ personal protection”.
Incompatible materials: Oxidizing agentsConditions for safe storage: Avoid sunlight.
Packing material: Use a sealed container without damage or leakage.
7.3. Specific end use(s)Hollow fiber membrane for manufacturing of medical products
Section 8: Exposure controls/personal protection
8.1. Control parameters
Acceptable concentration (exposure limit, biological exposure index)
OSHA PEL TWA
1000 ppm, 1900 mg/m3 (Ethanol)
ACGIH TLV-STEL (2014)
1000 ppm (Ethanol)
8.2. Exposure controls
Appropriate engineering controls:
Shower and eye washer should be available in the work area.
Under high temperature or in case of mist generation, use ventilation.
Personal protective equipment:
Respiratory protection: Wear appropriate protective mask as required.
Hand protection: If hand contact is possible, wear protective gloves.
Eye protection: Wear safety glasses or goggles if necessary.
Skin and body protection: Wear protective clothing and apron if necessary.
8.3. Individual protection measures, such as personal protective equipment:
Respiratory protection: Wear respiratory protective equipment if exposure tovapor/mist/spray is likely. PPE should be to European (EN) or US Standards. Consult
manufacturers concerning breakthrough times.
Skin protection: chemical resistant gloves (e.g., butyl or nitrile rubber) and suitable
protective clothing (e.g., apron, sleeves and boots).
Eye protection: Wear safety goggles.
8.4. Environmental exposure controls:
Take care to not release product into drains, sewers, and streams or other waterways.
Section 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties
Appearance:
Clear liquid(physical state, form and color)
Odor:
Characteristic odor
Odor threshold:No information
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Safety Data Sheet for BioOptimal MF-SLpH:
No information
Melting point/freezing point:
No information
Initial boiling point and boiling range: No information
Flash point:
No information
Evaporation rate:
No information
Flammability (solid, gas):
No information
Upper/lower flammability or
No information
explosive limits:
Vapor pressure:
No information
Vapor density:
No information
Relative density:
No information
Solubility (ies):
Miscible in water
Partition coefficient: n-octanol/water: No information
Auto-ignition temperature:
No information
Decomposition temperature:
No information
Viscosity:
No information
9.2. Other information
No information
Section 10: Stability and reactivity
10.1. Reactivity:
Stable under normal handling condition.
10.2. Chemical stability
Stable under normal handling condition.
10.3. Possibility of hazardous reactions
No hazardous reaction expected under normal handling.
10.4. Conditions to avoid
Avoid sunlight.
10.5. Incompatible materials
Oxidizing agents,
10.6. Hazardous decomposition products
In case of fire, toxic decomposition products may be generated.
Section 11: Toxicological information
11.1 Information on toxicological effects
Information on product:
No information
Information on ethanol:
Acute toxicity (oral):Rat LD50 = 6,200 mg/kg
Acute toxicity (dermal):Rabbit LDL0 = 20,000 mg/kg
Acute toxicity (inhalation: vapor): Rat LC50 = 63,000 ppmV
Skin corrosion/irritation:
Not irritating to rabbit skin.
Serious eye damage/irritation:
Moderately irritating to rabbit eyes.
Carcinogenicity:
IARC classified as Group 1.
Reproductive toxicity:
There are numerous reports that fetal alcohol syndrome
which is characterized by growth deficiency, microcephaly,

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characteristic facial characteristics and mental retardation,
was observed in the children of alcoholic women.
In an inhalation exposure test in humans, stupor,
drowsiness and slight paralysis were observed. In addition,
suppression of central nervous system was observed inexperimental animals.
Long-term consumption of large doses of alcohol causes
toxic effects in almost all organ systems. The mostaffected target organ is the liver; beginning with fatty
degeneration, damage can progress via necrosis andfibrotic stages to liver

STOT-single exposure:

STOT-repeated exposure:11.2 Delayed and immediate effects and also chronic effects from short and long term exposure
Causes eye irritation
May cause respiratory irritation
May cause drowsiness or dizziness
May cause cancer
May damage fertility or the unborn childCauses damage to liver through prolonged or repeated exposure
May causes damage to central nervous system through prolonged or repeated exposure
11.3 Numerical measures of toxicity
Acute toxicity was estimated based on ingredients of the product by additivity formula.
11.4 Interactive effects
No information
11.5 Whether the chemical is listed in the NTP Report on Carcinogens or has been foundto be a potential carcinogen in the IARC Monographs, or by OSHA
IARC: Group 1 (Ethanol)
NTP Report: Not listed
OSHA: Not listed
Section 12: Ecological information
12.1. Toxicity:
Information on product:

No information

Information on ethanol:
Aquatic acute toxicity:

Fish (Rainbow trout) 96-h LC50 = 11200 ppm
Crustacea (Daphnia magna) = 48-h EC50 = 5,463 mg/L
Algae (Chlorella) = 1,000 mg/L
Aquatic chronic toxicity: Crustacea (Ceriodaphnia) 10-d NOEC = 9.6 mg/L

12.2. Persistence and degradability:
Information on product:

No information

Information on ethanol:

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12.3. Bioaccumulative potential:
Information on product:

No information

Information on ethanol:

No information

12.4. Mobility in soil:
Information on product:

No information

Information on ethanol:

No information

12.5. PBT and vPvB in accordance with EU CLP: The product does not meet the criteria for
PBT or vPvB according to Regulation (EC) No 1907/2006, Annex XIII.
12.6. Other adverse effects:
No information
Section 13: Disposal considerations
13.1. Waste treatment methods
Dispose of waste in accordance with applicable local, regional and international regulations
and standards.
When disposing, consult to a licensed contractor or local offices if they deal with the waste.
Used container should be recycled after cleaning or dispose of in compliance with related
laws and local regulations.
Contents should be removed completely when dispose of empty containers.
Section 14: Transport information
14.1. UN number:
14.2. UN proper shipping name:14.3. Transport hazard class(es):14.4. Packing group:
14.5. Environmental hazards:
14.6. Special precautions for user:

Not applicableNot applicableNot applicableNot applicableNot applicable
When transporting, avoid direct sunlight.
Confirm no leakage to containers. When loading,prevent containers from falling, dropping off ordamaging. Take preventive measures ofcollapse.
14.7. Transport in bulk according to Annex II of MARPOL 73/78 and the IBC code
Not applicable

Section 15: Regulatory information
15.1. Safety, health and environmental regulations specific for the product in question
The product and its ingredients are not regulated by specific provisions related to protection ofhuman health or the environment at EU level, e.g. not considered as SVHCs or POPs.
UNITED STATESOSHA: Hazardous chemical
TSCA inventory: Ethanol is listed on the TSCA Inventory.
TSCA SNUR: Not listed

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15.2. Chemical safety assessment:

Not conductedSection 16: Other information
Update history:
Date of issue: December 15, 2015Date of most recent revision: October 1, 2018; Supersedes Version 1.0 issued December 15,
2015
Sections revised: Content changes were made to Sections 1 and 16.
References:
NITE GHS classification results (2015).
ACGIH, American Conference of Governmental Industrial Hygienists (2014) TLVs and BEIs.
Full text of Hazard statements referred to in Sections 2 and 3:
H226 Flammable liquid and vapor
H319 Causes eye irritation
H350 May cause cancer
H360FD May damage fertility or the unborn child
H335 May cause respiratory irritation
H336 May cause drowsiness or dizziness
H372 Causes damage to liver through prolonged or repeated exposure
Relevant hazard statements of which do not appear elsewhere in this SDS:
H225: Highly flammable liquid and vapor
Abbreviations
PBT: Persistent, Bioaccumulative and Toxic substancePOPs: Persistent Organic Pollutants
STOT: Specific Target Organ Toxicity
SVHC: Substances of Very High Concern
vPvB: Very Persistent and Very Bioaccumulative[Disclaimer]This SDS has been prepared based on the best available information however, it may not besufficient in some cases. It is user’s responsibility to modify or update any contents in this SDS
regarding information on hazardous properties and/or instruction for safe handling of the productwhen they become available. Precautionary measures in this SDS are only applicable for normal
handling conditions and it is necessary to take appropriate additional measures to ensure safe
handling which depend on your specific use conditions or situations

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